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CO-DYDRAMOL 10MG/500MG TABLETS

Active substance(s): DIHYDROCODEINE TARTRATE / PARACETAMOL / DIHYDROCODEINE TARTRATE / PARACETAMOL / DIHYDROCODEINE TARTRATE / PARACETAMOL

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Dihydrocodeine Tartrate and Paracetamol

Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or
pharmacist. Do not pass this medicine on to others. It may harm them, even if their symptoms are the same
as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
What is in this leaflet:
1. What co-dydramol is and what it is used for
4. Possible side effects
2. What you need to know before you take co-dydramol 5. How to store co-dydramol
3. How to take co-dydramol
6. Contents of the pack and other information

The name of your medicine is Co-dydramol 10mg/500mg Tablets (called co-dydramol throughout this leaflet).
Co-dydramol contains two different medicines called paracetamol and dihydrocodeine tartrate. It belongs to
a group of medicines called analgesics (painkillers) and is used to treat mild to moderate pain.

Important things you should know about co-dydramol
• Do not take for longer than your doctor tells you to.
• Taking co-dydramol regularly for a long time can lead to addiction, which might cause you to feel
restless and irritable when you stop the tablets.
• Taking a painkiller for headaches too often or for too long can make them worse.
Do not take co-dydramol and tell your doctor if:
• You are allergic to the active substances or any of the other ingredients in your medicine (listed in Section 6)
Signs of an allergic reaction include a rash and breathing problems. There can also be swelling of the legs,
arms, face, throat or tongue
• You have breathing problems
• You are having an asthma attack
• You have liver disease
• You are an alcoholic
Do not take co-dydramol if any of the above apply to you. If you are not sure, talk to your doctor or
pharmacist before taking co-dydramol.
Children
Co-dydramol must not be given to children under 12 years of age.
Warnings and precautions
Take special care and check with your doctor before taking co-dydramol if:
• You have kidney problems
• You have asthma
• You have problems with your thyroid gland (hypothyroidism)
• You are in the last three months of pregnancy (see Pregnancy and breast-feeding section)
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this
medicine.
Other medicines and co-dydramol
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes
medicines obtained without a prescription, including herbal medicines. This is because co-dydramol and
some other medicines can affect the way each other work.
While taking co-dydramol you should not take any other medicines which contain
paracetamol.
This includes some painkillers, cough and cold remedies. It also includes a wide range of other medicines
available from your doctor and more widely in shops.
Tell your doctor if you are taking any of the following medicines:
• Medicines to treat depression called MAOIs (monoamine oxidase inhibitors) such as moclobemide,
phenelzine, tranylcypramine or have taken them in the last 2 weeks.
• Medicines which make you drowsy or sleepy
• Medicines used to thin the blood such as warfarin
• Metoclopramide or domperidone - used to stop you feeling or being sick (nausea or vomiting)
• Colestyramine - for lowering blood cholesterol levels
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking
co-dydramol.
Co-dydramol with alcohol
You should not drink alcohol while you are taking these tablets.
Pregnancy and breast-feeding
Talk to your doctor before taking these tablets if:
• You are pregnant, think you may be pregnant or plan to get pregnant.
• You are breast-feeding or planning to breast-feed
Driving and using machines
Co-dydramol can affect your ability to drive as it may make you sleepy or dizzy.
• Do not drive whilst taking this medicine until you know how it affects you
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber or in the information provided with
the medicine and
- It was not affecting your ability to drive safely

Artwork Approval
History Reference
No. : V.F. 2689029
REGULATORY
PACKAGING
QUALITY

Always take co-dydramol exactly as your doctor has told you. Check with your doctor or pharmacist if you
are not sure.
• Do not take more than the recommended dose
• Do not take for longer than your doctor tells you to
• Swallow the tablets whole with a glass of water
Adults and children over 16 years: 1 to 2 tablets every 4 to 6 hours when necessary up to a maximum
of eight tablets in 24 hours. Elderly people may be prescribed a lower dose.
Use in children aged 12 to 15 years: 1 tablet every 4 to 6 hours when necessary to a maximum of
4 tablets in 24 hours.
Co-dydramol should not be given to children under 12 years of age.
If you take more co-dydramol than you should
• Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too
much paracetamol can cause delayed, serious liver damage.
• Remember to take any remaining tablets and the pack with you. This is so the doctor knows what you
have taken
If you forget to take co-dydramol
If you forget to take a dose at the right time, take it as soon as you remember. However do not take a
double dose to make up for a forgotten dose. Remember to leave at least 4 hours between doses.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following
side effects may happen with this medicine:
Important side-effects you should know about co-dydramol
• Taking a painkiller for headaches too often or for too long can make them worse.
• Taking co-dydramol regularly for a long time can lead to addiction, which might cause you to feel restless
and irritable when you stop the tablets.
Stop taking co-dydramol and see a doctor or go to a hospital straight away if:
• You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or
breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria)
This may mean you are having an allergic reaction to co-dydramol.
• You get serious skin reactions. Very rare cases have been reported.
Talk to your doctor straight away if you notice any of the following serious side effects:
• Severe stomach pain, which may reach through to your back. This could be a sign of inflammation of the
pancreas (pancreatitis). This is a very rare side effect.
Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer
than a few days:
• Constipation, feeling sick (nausea), being sick (vomiting)
• Headache, dizziness, light-headedness, drowsiness, confusion
• Becoming dependent on dihydrocodeine
• You get infections or bruise more easily than usual. This could be because of a blood problem.
• Redness or blood spots on the skin (purpura)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via the Yellow card Scheme
at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the
safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date shown on the pack. The expiry date refers to the last day of
that month.
Store your medicine in the original packaging in order to protect from moisture.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help protect the environment
What Co-dydramol Tablets contain
• The active substances are 500mg of paracetamol and 10mg of dihydrocodeine tartrate. The other
ingredients are pregelatinised starch, maize starch, povidone, potassium sorbate, microcrystalline
cellulose, stearic acid, purified talc and magnesium stearate.
What Co-dydramol Tablets look like and contents of the pack
Flat bevelled edge white tablets, marked S/8 on one side. They come in cartons of 30 and 100 tablets.
The Marketing Authorisation Holder and Manufacturer is Zentiva, One Onslow Street, Guildford,
Surrey, GU1 4YS, UK.
This leaflet was updated in January 2017

Artwork Number : ZEN-0996017-3tt-UK-EX
Version Number : 2
Edition Number : 3
Product
: Co-Dydramol Tablets
Artwork Type
: Leaflet
Dimensions(mm) : 140 x 260 mm
SAP Item Code
: 541900
Technical Drawing : APA
Machine
: IC-150-C/ CAM
Style \ Folds
: APA
Minimum font size : 7.5
Pharma Code No. : 9960
EAN bar Code No : NA

ZEN-0996017-3tt-UK-EX
Co-dydramol TABS
-30’s & 100’s pack[541900]

CO-DYDRAMOL 10mg/500mg TABLETS

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive whilst taking this
medicine.
Changing or stopping treatment
Taking co-dydramol for a long time may lead to tolerance and dependence. Do not increase or suddenly
stop treatment without discussing this with your doctor.

Date
Colours
1. Black

: 23.02.17

Braille
:
Non-Varnish zones:
Outline
:

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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